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Predicting Acute Compartment Syndrome (PACS)

NCT01561261 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2018-08-15

No results posted yet for this study

Summary

The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis of acute compartment syndrome (ACS).

The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (specific clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring).

Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data:

* A physiologic "fingerprint" composed of continuous pressure versus time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels).
* Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the Short Musculoskeletal Function Assessment (SMFA).

Conditions

  • Acute Compartment Syndrome

Interventions

OTHER

Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP)

Continuous monitoring of tissue perfusion using NIRS in all 4 leg muscle compartments and IMP via indwelling catheters in anterior and deep posterior compartments. These measures will not provided in real time to treating physicians. All clinical care, including the diagnosis of ACS, will be according to the current standard-of-care practiced at each institution, Clinicians may use the indwelling IMP monitor to obtain up to 2 discrete measures of IMP if they encounter a clinical situation in which they would normally measure IMP as an adjunct in their normal standard-of-care for the monitoring and diagnosis of compartment syndrome. Patients who undergo fasciotomy will also have NIRS and IMP values recorded from all 4 leg compartments immediately before and after fasciotomy.

Sponsors & Collaborators

  • Major Extremity Trauma Research Consortium

    lead OTHER

Principal Investigators

  • Andrew Schmidt, MD · Hennepin County Medical Center / UMN

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-12-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01561261 on ClinicalTrials.gov